ROWASA Drug Patent Profile
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When do Rowasa patents expire, and when can generic versions of Rowasa launch?
Rowasa is a drug marketed by Mylan Speciality Lp and Meda Pharms and is included in two NDAs.
The generic ingredient in ROWASA is mesalamine. There are twenty-eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Rowasa
A generic version of ROWASA was approved as mesalamine by PADAGIS ISRAEL on September 17th, 2004.
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Questions you can ask:
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Summary for ROWASA
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 181 |
| Clinical Trials: | 3 |
| Patent Applications: | 4,725 |
| Drug Prices: | Drug price information for ROWASA |
| What excipients (inactive ingredients) are in ROWASA? | ROWASA excipients list |
| DailyMed Link: | ROWASA at DailyMed |
Recent Clinical Trials for ROWASA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dayanand Medical College and Hospital | Phase 3 |
| Colitis & Crohn's Foundation (India) | Phase 3 |
| Altheus Therapeutics, Inc. | Phase 1 |
Pharmacology for ROWASA
| Drug Class | Aminosalicylate |
US Patents and Regulatory Information for ROWASA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618-001 | Dec 24, 1987 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Meda Pharms | ROWASA | mesalamine | SUPPOSITORY;RECTAL | 019919-001 | Dec 18, 1990 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ROWASA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618-001 | Dec 24, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618-001 | Dec 24, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ROWASA
See the table below for patents covering ROWASA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| New Zealand | 578674 | REDUCED IRRITANT ENEMA FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (IBD) | ⤷ Sign Up |
| Canada | 2677095 | LAVEMENT AMELIORE A EFFET IRRITANT REDUIT DESTINE AU TRAITEMENT D'UNE AFFECTION INTESTINALE INFLAMMATOIRE (IBD) (IMPROVED REDUCED IRRITANT ENEMA FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (IBD)) | ⤷ Sign Up |
| Denmark | 2107870 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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